Cardiopulmonary resuscitation has not fulfilled its original expectations, and the prognosis for patients remaining in cardiac arrest more than ten minutes remains poor (Becker AB, Ann Emerg Med, 20:355 (1991)). Indeed, cardiopulmonary resuscitation has recently been termed a "spectacular failure" in which only a small minority of patients have been successfully resuscitated (Barsan WG, JAMA, 265:3115-3118 (1991)). Standard advanced cardiac life support (ACLS) has only limited efficacy after the first few minutes of cardiac arrest. Studies in animal models have shown that vital organ blood flow, and thus oxygen delivery, during CPR is poor (Ditchey RV, et al, Circ, 66:297-302 (1982); Ditchey RV et al, Cardiovasc Res, 19:419-425 (1985); and Taylor RB, et al, Resuscitation, 16:107-118 (1988)). Indeed, CPR generally provides only a small fraction of normal oxygen supply to the brain and heart, and even less to other organs. Recent human studies have confirmed that perfusion pressures, the driving force for organ blood flow, are inadequate in humans during CPR (Paradis NA, et al, Circ, 80:361-368 (1989); Paradis NA, et al, JAMA, 263:1106-1113 (1990); and Martin GB, et al, Ann Emerg Med, 15:125-130 (1986)). High-dose epinephrine, open chest CPR, and cardiopulmonary bypass increase perfusion pressure (Paradis NA, et al, JAMA, 265:1139-1144 (1991); Martin GB, et al, Ann Emerg Med, 16:628-636 (1987); and Howard MA, et al, Ann Emerg Med, 15:664-665 (1986)). However, these are not effective in all patients, or require significant resources not generally available.
In an effort to find simple but effective methods to improve perfusion during CPR, a number of mechanical intravascular based therapies have been investigated. Among these are arterial and venous volume infusion and aortic occlusion (Gentile NT, et al Crit Care Med, (1990) (in press); Abu-Nema T et al, Circ Shock, 4:55-62 (1988); Suzuki A et al, Jpn J Anesthesiol, 29:677-682 (1980); Spence PA, et al, J Surg Res, 49:217-221 (1990)); and Manning JEet al, Ann Emerg Med, 19:212 (1990). These techniques, however, have failed to improve outcome. Standard aortic counter-pulsation that is without distal aortic occlusion, may improve perfusion, but not enough to significantly improve outcome (Emerman CL, et al, Am J Emerq Med, 7:378-383 (1989)). Simple balloon occlusion, with or without volume infusion, does not appear to be effective.
It is known to provide oxygenated fluorocarbon emulsions to-transport oxygen to oxygen deprived brain tissue (see U.S. Pat. No. 4,927,623 to Long, Jr.).
Balloon catheter devices and methods are known for directing blood toward the heart during spontaneous circulation (see, for example, U.S. Pat. Nos. 4,407,271 to Schiff; 4,804,358 to Karcher et al; 4,601,706 to Aillon; and 4,459,977 to Pizon et al).
Such catheter devices with two or more balloons are also known (see, for example, U.S. Pat. Nos. 4,531,936 to Gordon; 4,527,549 and 4,741,328 to Gabbay; 4,697,574 to Karcher et al.; 5,176,619 to Segalowitz; and 4,771,765 and 4,902,273 to Choy et al.). None of these devices were designed or intended for use during cardiac arrest.